Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The peri-endoscopy management of diabetes mellitus creates significant challenges for both patients and healthcare professionals. These procedures require fasting and in certain situations, such as prior to a colonoscopy, the diet must be modified the day before the intervention and patients need to take a laxative. These factors put patients at high risk for hyperglycemia and hypoglycemia. Inadequate diabetes control or the continuation of certain medications during this period can be dangerous for the patient and lead to the cancellation of the procedure.
DIAPI is a web application designed to generate orders for optimal and personalized treatment based on each patient's antidiabetic treatment, their glycemic control, their risk of hypoglycemia, and the intervention-related variables. DIAPI's algorithm is established on current evidence-based data when available, and experts' opinions.
Information generated by DIAPI:
For the patient: Clear instructions regarding their diabetes medication management for the days preceding and the day of the endoscopy.
For the health care team:
DIAPI aims to simplify the complex task of peri-intervention diabetes management while ensuring patient safety. It is a cost-effective solution that can lead to a reduction of unnecessary Endocrinology consultations, a decrease in nurses' workload, a lessening of the risk of errors and a diminution of endoscopy cancellation.
The validation study is divided into two main phases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Patients will receive usual care for their diabetes during their peri-procedural period. |
|
| DIAPI | Experimental | Patients will receive the care for their diabetes recommended by the DIAPI algorithm during their peri-procedural period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peri-intervention Diabetes Management Algorithm (DIAPI) | Other | Patients and healthcare workers will apply DIAPI's orders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate of duplicate prescriptions generated by DIAPI when two different healthcare workers collect data for the same patient. (Part 1 of study) | Concordance and discordance are dichotomic concepts. To classify this binary issue, the investigators use a home-made ''Difference Score''. The components of this score have been established to ensure patient safety by minimizing the risk of hypoglycemia, hyperglycemia, and diabetic ketoacidosis.
| 1 week |
| proportion of patients with glycaemia level within target from arrival to departure from the endoscopy unit, i.e. between 4 - 10 mmol/L. (Part 2 of study) | The glycaemia will be measured at least every hour for the duration of the stay in the endoscopy unit. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of DIAPI orders for which the endocrinologist disagrees with at least one of its recommendations. (Part 1 of study) | 1 week | |
| Proportion of participants for whom an endocrinology consultation was recommended by DIAPI. (Part 1 of study) | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Marie Boutin, MD, PhD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0C1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual Care | Other | Patients and healthcare workers will apply the mainstay management, which is using the treating-physician's recommendations instead of DIAPI's. |
|
| Healthcare workers' satisfaction level with the use of DIAPI, assessed by a questionnaire. (Part 1 of study) | 1 week |
| Proportion of participants who followed DIAPI recommendations. (Part 2 of study) | 1 week |
| • Proportion of canceled endoscopies due to dysglycemia, ketoacidosis or for reasons related to diabetes management. (Part 2 of study) | 1 week |
| Proportion of participants hospitalized for a diabetes-related condition. (Part 2 of study) | 1 month |
| Proportion of participants who experienced: episode of hypoglycemia <3 and < 4 mmol/L, episode of hyperglycemia >10, > 15 and >20 mmol/L, episode of ketoacidosis. (Part 2 of study) | These episodes will be reported by time frame: the day before, the same day and the day after the intervention. | 1 week |